Printed from Voxsanity (voxsanity.com.au) — NCT07669610 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 3 Breast Cancer Trial, Not Yet Recruiting
NCT07669610
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- Women aged 18 to 70 years.
- People whose general health and ability to carry out daily activities is rated as fully active or restricted only in physically strenuous activity (confirm with trial site for exact rating scale used).
- People with a life expectancy of at least 3 months.
- People who have been diagnosed through tissue testing with a specific type of breast cancer called triple-negative breast cancer — meaning the cancer tests negative for estrogen receptor, progesterone receptor, and HER2 — and whose cancer has also been confirmed to belong to a particular subtype called BLIS under a four-group classification system used at the participating centre.
- People whose breast cancer has come back or spread to other parts of the body, or whose locally returned cancer has been assessed by the investigating doctor as unable to be fully removed by surgery, and who have received no more than 2 prior treatment courses for advanced disease.
- People who have at least one area of cancer that has not previously been treated with radiation, can be measured or assessed by CT or MRI scan at the start of the trial, and can be checked again over time using standard response criteria.
- People whose blood and organ function meets required levels, including: haemoglobin of 90 g/L or above (without a blood transfusion in the past 14 days); neutrophil count of 1.5×10⁹/L or above; platelet count of 75×10⁹/L or above; liver and kidney function values within acceptable ranges as determined by the trial site.
- People who have not had radiotherapy, hormone therapy, targeted therapy, or surgery within the 3 weeks before starting the trial, and who have recovered from side effects of any previous treatment, with no nerve-related side effects or only very mild ones (grade I).
- People of childbearing potential who agree to use a medically accepted method of contraception throughout the treatment period and for at least 3 months after the last dose of the study drug.
- People who are willing to take part voluntarily, sign a consent form, follow the study requirements, and attend follow-up appointments.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People with known cancer spread to the brain or spinal cord (central nervous system), or a past history of this.
- People with a significant or uncontrolled heart condition, including heart failure, chest pain (angina), a heart attack in the past 6 months, or serious irregular heart rhythms.
- People who still have ongoing side effects of grade 1 or higher from previous treatments, with the exception of hair loss or other conditions the investigating doctor considers acceptable for enrolment (confirm with trial site).
- People who have had major surgery within 3 weeks before starting the first treatment cycle (minor procedures such as insertion of a vascular access device are not included in this restriction).
- People who are pregnant or breastfeeding.
- People who have had another cancer in the past 5 years, except for certain skin cancers or cervical carcinoma in situ that have been fully treated and cured.
- People who have a build-up of fluid in body cavities, such as large amounts of fluid around the lungs or in the abdomen, that cannot be controlled by drainage or other means.
- People who have participated in another clinical trial of an anti-cancer drug within 3 weeks before the first dose of the study drug.
- People with wounds that have not healed over a long period, or bone fractures that have not fully healed.
- People with an active hepatitis B or hepatitis C infection, a hepatitis B viral load at or above a certain level, or chronic hepatitis with abnormal liver function results.
- People with a known history of serious allergies, a known allergy to any part of the study drug, or a history of allergic reactions to other monoclonal antibody treatments.
- People with a history of gastrointestinal (digestive tract) bleeding in the past 6 months, or signs of a high risk of such bleeding, such as certain enlarged veins in the oesophagus, active ulcers, or certain stool blood test results (confirm with trial site for specific thresholds).
- People who have had an abdominal fistula (an abnormal connection in the digestive system), a hole in the gastrointestinal tract, or an abscess inside the abdomen within 28 days before joining the study.
- People whose urine tests show a protein level above a certain threshold, or whose 24-hour urine protein measurement is above 1.0 g (confirm with trial site for exact urine test thresholds).
- People with high blood pressure that remains above 140/90 mmHg even with blood pressure medication.
- People who have previously been treated with anti-angiogenic drugs (drugs that block blood vessel growth in tumours), or with a type of targeted drug called an antibody-drug conjugate (ADC) that uses a topoisomerase I inhibitor as its active component.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Phone: 02164175590
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
1 October 2026
Est. completion
30 September 2028
Primary endpoints
Progression Free Survival(PFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.